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Risk Management

As new technologies and the FDA have redefined the role of the dental laboratory, owners have new risks to consider.

By Mark C. Jackson, RDT

Dental laboratory owners face demands quite different than just a decade ago. Medical device manufacturers, in general, and dental laboratories, in particular—unlike many other industry segments—have had to quickly learn that staying competitive requires more than just keeping pace with changes in manufacturing technology. It also means staying up to date with regulatory affairs and shifting market demand and working with materials that are much more expensive, specialized, and technique-sensitive.

Many years ago, a friend asked the author why his facility was called a laboratory; as far as he could see, they were not doing any experiments or conducting any research. “In here, every day is an experiment,” the author told him. Of course, back then laboratories were often working with unproven materials and frequently had to come up with their own troubleshooting techniques and provide their own technical support. But that is not the case today, provided that dental laboratories follow the manufacturer’s instructions, use materials approved by the US Food and Drug Administration, and implement good manufacturing practices (GMPs).

But simple compliance with regulatory issues is not enough today. Laboratory businesses are at risk every time approved materials are not used for the purposes indicated, are mixed and matched with different materials, or when substitutions are made for recommended materials. When different materials are mixed and matched or one ingredient is substituted for another, the laboratory has effectively altered a 510(k)-approved system. If the finished product fails in the mouth, no product liability carrier is going to cover that event. It is important that laboratories use only FDA-registered materials, and for liability and safety reasons, use them only as directed.

Due Diligence

Unfortunately, many laboratory owners assume that as long as the product has received the dentist’s stamp of approval, everything is fine. The problem is that dentists increasingly ask laboratories to advise them on what materials would work best for a certain case or demand that a material be used for an indication not approved by the FDA. When this happens, even under a dentist’s direction, there is most certainly a product liability issue. In the event of a product failure involving injury to the patient, undoubtedly the product liability underwriter will call foul.

Good medical practice and the best interests of the patient require that medical device manufacturers, including laboratories, only use controlled materials based on current regulations as well as their best knowledge and judgment. If a product is used for an indication that is not listed in the approved labeling, the manufacturer has the responsibility to be well-informed about the product, to base its use on sound medical evidence, and to maintain records of the product’s use and effects. Product liability carriers may even require that patients sign consent and liability waivers. Theoretically, a laboratory using materials in an off-label manner (such as using a zirconia framework material as a full-contour restoration) could even be accused of performing an undocumented clinical trial on an unsuspecting patient. A defective restoration may not carry significant health risks, but use of unapproved, imported, or gray-market materials could have disastrous effects on the industry, as witnessed in the 2008 case of the Ohio woman who became ill with lead poisoning that was traced back to her new crown, which was manufactured in China and tested at 160 parts per million. The failure of a dental appliance is unlikely to cause serious injury or death. However, if the laboratory were to fabricate a surgical guide that caused a severely misplaced implant, resulting financial losses could be attributed to the laboratory technician’s misrepresentation of the product’s capabilities.

Protect Yourself

As the role of dental technicians continues to expand and evolve, laboratory owners should consider the benefits of securing professional liability insurance for their businesses. Professional liability insurance, also called professional indemnity insurance, protects against potential negligence claims made by patients or clients. Common reasons alleged in making claims on these policies are negligence, misrepresentation, and inaccurate advice. Due to the significant variation in the law governing liability over defective products, consult with a lawyer who has experience in handling these types of cases when evaluating risk and insurance coverage.

An old technician once said, “If it passes the lips, it fits.” That may have been the case a few decades ago, but not in today’s litigious society. With the responsibilities that come along with the title of medical device manufacturer, laboratories must weigh the risks and benefits of manufacturing the products they sell against their qualifications to fill the dentist’s prescription and their willingness to accept responsibility for a complication or failure if one occurs.

Asking the Pertinent Questions

To avoid a costly lawsuit and damages to your laboratory’s reputation, it is important to consider your qualifications and the risks that are involved before accepting a dentist’s request to manufacture a device. Asking yourself these hard-line questions before taking on a new case will help you to ensure that you are indeed qualified to do the job and also prepared to defend yourself should your laboratory get involved in a lawsuit.

Are you competent to manufacture the product?

Even though the dentist asked you to make it, do you feel qualified to accept the challenge? Has the dentist given you all the information you need or do you need to ask for more?

Do you have documentation of your specialized education and experience in this area?

Does the manufacture of the device require FDA registration?

Is your laboratory compliant with the FDA’s good manufacturing practices?

Do you have a competent authority (besides the dentist) to review your design?

Will your product liability insurance cover this product or will it violate your policy?

Do you need professional liability insurance in addition to your product liability insurance?